Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients With Controlled Cancers.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants with Moderate COVID-19:
研究概览
简要总结
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
- Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.
- Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen.
- The human antigen presenting cells (APCs) can take up and process COVID-19 target antigen protein into small peptide fragments, and then COVID-19 virus can be killed by APCs directly.
详细描述
- Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
- 20 Moderate COVID-19 patients with controlled cancers
- Moderate COVID-19
- Positive testing by standard RT-PCR assay or equivalent testing
- Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
- Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
- No clinical signs indicative of Severe or Critical Illness Severity
- Novavax COVID-19 Vaccine 1.0 mL plus BCG Organism 50 MG Mix
- By the percutaneous route with the multiple puncture device
- Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection 3 weeks.
- Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days.
- Our trial duration will be 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conducting an initial small, controlled trial to assess therapeutic biologics activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients with controlled cancers.
- •20 Moderate COVID-19 patients with controlled cancers
- •Inclusion Criteria:
- •Controlled Cancers
- •Moderate COVID-19
- •Positive testing by standard RT-PCR assay or equivalent testing
- •Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
- •Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
- •No clinical signs indicative of Severe or Critical Illness Severity
排除标准
- •1. Uncontrolled Cancers
- •2. Severe or Critical Illness Severity
- •3. Pregnancy
- •4. Breast-feeding
- •5. The patients with other serious inter-current illness
- •6. Serious Allergy
- •7. Serious Bleed Tendency
- •8. The prohibition of the biological product
研究组 & 干预措施
Assess for therapeutic biologics activity (proof-of-concept)
Therapeutic Biological Product Mix activity - NOVAVAX COVID-19 VACCINE 1.0 mL add into BCG Organism 50 MG
干预措施: COVID-19 Therapeutic Biologic Mix - NOVAVAX COVID-19 VACCINE plus BCG Vaccine Mix for percutaneous use (Biological)
结局指标
主要结局
Number of Participants with Moderate COVID-19:
时间窗: Duration at least 28 days
* 20 Moderate COVID-19 patients with controlled cancers * Moderate COVID-19 * Positive testing by standard RT-PCR assay * Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion * Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute * No clinical signs indicative of Severe or Critical Illness Severity
Rate of Negative COVID-19 nucleic acid
时间窗: Duration at least 28 days
* 20 Moderate COVID-19 patients with controlled cancers * NOVAVAX COVID-19 VACCINE 1.0 mL plus BCG Organism 50 MG Mix * By the percutaneous route with the multiple puncture device * Negative COVID-19 by standard RT-PCR assay after percutaneous use 3 weeks * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Negative COVID-19 nucleic acid will be more than 80%
20 COVID-19 Participants with IGRA blood test with COVID-19 spike protein antigen
时间窗: Duration at least 28 days
Positive IGRA blood test with COVID-19 spike protein antigen after percutaneous use 21 days
20 COVID-19 Participants with IGRA blood test with TB antigens
时间窗: Duration at least 28 days
* Negative IGRA blood test with TB antigens before percutaneous use * Positive IGRA blood test with TB antigens after percutaneous use 21 days
Rate of Positive COVID-19 nucleic acid:
时间窗: Duration at least 28 days
* 20 Moderate COVID-19 patients with controled cancers * Positive testing COVID-19 by standard RT-PCR assay immediately * COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit * Rate of Positive COVID-19 nucleic acid must be 100%
次要结局
未报告次要终点
研究者
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair
Medicine Invention Design, Inc